NCT01050595Unknown3 期
Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit
St. John Health System, Michigan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.
研究概览
简要总结
The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older in the ICU
- •Opioids for analgesia for at least 24 hours.
- •Opioid-induced constipation with no bowel movement within the last 72 hours.
- •Women of childbearing potential had negative pregnancy tests.
排除标准
- •Contraindication to use of the GI tract
- •Diarrhea on admission
- •Bowel surgery within 8 weeks of admission
- •Ileostomy or colostomy
- •Not expected to live or stay more than 3 days in the intensive care unit
- •Constipation that was not primarily caused by opioids (as determined by the investigator)
- •No opioid use in the last 24 hours,
- •Mechanical gastrointestinal obstruction
- •An indwelling peritoneal catheter
- •Clinically active diverticular disease
- •Fecal impaction
- •Acute surgical abdomen
- •History of Crohn's disease or ulcerative colitis
- •On Palliative care
- •Less than 18 years old
- •Bowel movement in last 72 hours.
研究组 & 干预措施
Methylnaltrexone Bromide
Active Comparator
干预措施: Methylnaltrexone Bromide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo-Normal Saline (Drug)
结局指标
主要结局
A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.
时间窗: Nine months
次要结局
- Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.(Nine months)
研究者
研究点 (1)
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